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Rituximab Ups Survival in Aggressive and Indolent NHL

Rituximab Ups Survival in Aggressive and Indolent NHL

January 01, 2002

ORLANDOPresentations at the 43rd Annual Meeting of the American
Society of Hematology (ASH) showed increased survival for patients with
aggressive and indolent non-Hodgkin’s lymphoma (NHL) who received the
anti-CD20 monoclonal antibody rituximab (Rituxan) in addition to standard CHOP
chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone).

At a median of 24 months follow-up, the Groupe d’Etude des Lymphomes de l’Adulte
(GELA) phase III study showed a 23% relative increase in overall survival in
patients with aggressive NHL treated with rituximab plus CHOP vs CHOP alone
(abstract 3025). In a phase II indolent NHL study of rituximab plus CHOP,
progression-free survival has not been reached at more than 5.4 years of
follow-up (abstract 2519).

In the GELA study, 399 previously untreated patients age 60 and older with
stage II to IV diffuse large B-cell lymphomas were randomized to receive either
standard CHOP alone every 3 weeks for eight cycles or rituximab 375 mg/m0178 plus
CHOP. Rituximab was administered on day 1 of each cycle.

Two-year event-free survival improved significantly from 37% in the CHOP
alone arm to 57% in the combination arm, a relative increase of 54%. Event-free
survival was defined as ongoing survival without events, including disease
progression or relapse, death, or initiation of new alternative treatment.

Overall survival at 2 years was increased from 57% in the CHOP alone arm to
70% in the rituximab/CHOP arm, a relative increase of 23%. "This is the
first new drug combination in more than 20 years to show an improvement in
overall survival for patients with aggressive NHL," said principal
investigator Bertrand Coiffier, MD, of the Hospices Civils de Lyon, France.

At 18 months, complete response rate increased from 64% in the CHOP alone
arm to 77% in the combination arm, a relative increase of 20% (P = .007).

Case Study

In his ASH poster presentation, Dr. Myron Czuczman described the case of a
42-year-old man diagnosed with stage IIA follicular mixed CD20+ lymphoma. One
residual mass was 6 cm in maximum diameter. The patient tested positive for
bcl-2 in blood and marrow.

The patient achieved a complete remission at completion of therapy and
remains in remission at more than 6.5 years post-therapy. He converted to and
remains bcl-2 negative by serial sampling.

Apart from grade 3-4 first-infusion events, experienced by approximately 10%
of patients in the rituximab/CHOP arm, toxicity was not increased by the
addition of rituximab to CHOP chemotherapy, Dr. Coiffier said.